Deficiencies in Planning Interventional Trial Registration of COVID-19 in China

Frontiers in Medicine

article

Xiaodan Li¹  Shengzhao Zhang²  Yiling Zhou⁴  Ying Liu²  Youlian Zhou⁴  Sheyu Li⁵  Na Su² 

[1] Department of Gastroenterology, West China Hospital, Sichuan University;Department of Pharmacy, West China Hospital, Sichuan University;West China School of Pharmacy, Sichuan University;Department of Endocrinology and Metabolism, West China Hospital, Sichuan University;Department of Guideline and Rapid Recommendation, Cochrane China Center, MAGIC China Center, Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University

关键词: COVID-19;    SARS-CoV-2;    interventional trials;    registries;    China;    sample size index;   

DOI  :  10.3389/fmed.2021.618185

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China. Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/ ) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/ ) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria. Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1. Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence.

【 授权许可】

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